MOTION SICKNESS II- meclizine hcl tablet
TOP CARE (Topco Associates LLC)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

for prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

Warnings

Do not use

for children under 12 years of age unless directed by a doctor.

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

to prevent motion sickness, the first dose should be taken 1 hour before starting activity
adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
do not exceed 2 tablets in 24 hours

Other information

store between 20-25ºC (68-77ºF)

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminium lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

Call toll free: 1-888-423-0139

Principal Display Panel

COMPARE TO DRAMAMINE® LESS DROWSY FORMULA ACRIVE INGREDIENT*

LESS DROWSY FORMULA

Motion Sickness Relief

MECLIZINE HCI, 25 mg - ANTIEMETIC

LONG LASTING

Up to 24 Hours of Protection
Prevents Nausea, Dizziness and Vomiting

TABLETS

*This product is not manufactured or distributed by Prestige Brands, Inc., distributor of Dramamine® Less Drowsy Formula.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

TOPCARE HEALTH Motion Sickness Relief

MOTION SICKNESS II
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-620
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL086
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-620-08	1 in 1 CARTON	05/31/2013	12/30/2022
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part336	05/31/2013	12/30/2022

Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 11/2020

Document Id: 1f2ff61e-3687-4134-8481-30a7e75e5831

Set id: 9b980e34-a0a5-4d33-9f23-d91b837d8edd

Version: 5

Effective Time: 20201110

TOP CARE (Topco Associates LLC)